Venous MalformationPhase 4NCT01347294
Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations
A Phase 4 study testing Bleomycin, Fibrovein and Bleomycin + Fibrovein in people with Venous Malformation, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to determine the effectiveness of bleomycin, fibrovein and bleomycin and fibrovein in the treatment of venous malformation. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Venous Malformation
- What is being tested?
- Bleomycin, Fibrovein and Bleomycin + Fibrovein
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2011to 30 Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of Venous malformation
- Must be able to fill in questionary form
- Must be able to sign informed consent form
Who cannot join
- Kidney disease
- Lung disease
- Pregnancy or not willing to safe contraception
- Allergy to Bleomycin or Fibrovein
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compare the Effect of Bleomycin and Tetradecyl Sodium Sulphate in the Treatment of Venous Malformations
The purpose of this study is to determine the effectiveness of bleomycin, fibrovein and bleomycin and fibrovein in the treatment of venous malformation.
Read the detailed description
Patients with scanty symptoms from their vascular malformation can do well with conservative treatment and / or with aids and adaptations in daily life. Compression therapy (elastic stockings), pain medication and good counseling is adequate for many. Patients with significant symptoms, however, may require more invasive treatment. Previously, it was common with surgical removal, but serious sequelae and frequent recurrence after surgery resulted in caution. Today it is more common with intervention radiology treatment with injection of sclerosing agents into existing malformation. This type of therapy almost always requires repeated treatment sequences, sometimes over several months. Treatment aims to seal blood vessels in the malformation and / or make the patient as possible symptoms. Recurrence occurs frequently and there are many who are not completely free from symptoms. Many patients have chronic problems with pain, wounds, bleeding and / or they have a cosmetically disfiguring condition. Predicting the performance of a specific type of treatment can be very difficult.
Until now, there are some studies that have considered the effect of bleomycin / pingyangmycin (China) and ethanol in the treatment of vascular malformations. To our knowledge there is no prospective or retrospective studies that compare the efficacy and side effects of bleomycin and sodium tetradecyl sulfate (Fibrovein ™) in the treatment of VM.
- Conditions
- Venous Malformation
- Being tested
- Bleomycin, Fibrovein, Bleomycin + Fibrovein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BleomycinDrug
Also called Bleomycin Baxter
Intralesional
FibroveinDrug
Also called Fibrovein S.T.D pharmaceutical products LTD
Intralesional
Bleomycin + FibroveinDrug
Also called Bleomycin Baxter + Fibrovein pharmaceutical products
Intralesional
| Study group | Role | What they receive |
|---|---|---|
| Bleomycin + Fibrovein | Experimental | 1) Fibrovein 3% foamed with air 50/ 50. Total volum injected is the same as volume of malfomation. Volume of malformation estimated by contrast media injection before sclerotherapy.
2) wait 5 minutes
3) Bleomycin 1000 iu / ml. Injected volume same as volume of Fibrovein foam. Receives: Drug: Bleomycin + Fibrovein |
| Bleomycin | Active comparator | Bleomycin 1000 iu/ ml. Total volum injected is the same as volume of malfomation. Volume of malformation estimated by contrast media injection before sclerotherapy. Receives: Drug: Bleomycin |
| Natrium Tetradecyl Sulphate (Fibrovein ) | Experimental | Fibrovein 3% foamed with air 50/ 50. Total volum injected is the same as volume of malfomation. Volume of malformation estimated by contrast media injection before sclerotherapy. Receives: Drug: Fibrovein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intesity, frequency and type of pain.
Pain will be measured before, during and after treatment. It will be asked about type, characteristics and intensity of pain. Using the Visual Analog Score 0-10, 0 beingno pain,10 being maximum pain, will be used in this matter.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startAug 2011
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous MalformationStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rune Andersen, Oslo University Hospital
- Investigators
- Andreas Abildgaard, Phd, Study director, Oslo Universitetssykehus, Rikshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347294
- Sponsor's protocol ID
- 1331TMF
- Other IDs
- TMF1331
- Status last verified
- Nov 2023
- First submitted
- 11 Apr 2011
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Effect of Bleomycin and Tetradecyl Sodium Sulphate in the Treatment of Venous Malformations
- ClinicalTrials.gov ID
- NCT01347294
- Acronym / sponsor ID
- 1331TMF
- Conditions
- Venous Malformation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 4 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of bleomycin, fibrovein and bleomycin and fibrovein in the treatment of venous malformation.
Detailed description
Patients with scanty symptoms from their vascular malformation can do well with conservative treatment and / or with aids and adaptations in daily life. Compression therapy (elastic stockings), pain medication and good counseling is adequate for many. Patients with significant symptoms, however, may require more invasive treatment. Previously, it was common with surgical removal, but serious sequelae and frequent recurrence after surgery resulted in caution. Today it is more common with intervention radiology treatment with injection of sclerosing agents into existing malformation. This type of therapy almost always requires repeated treatment sequences, sometimes over several months. Treatment aims to seal blood vessels in the malformation and / or make the patient as possible symptoms. Recurrence occurs frequently and there are many who are not completely free from symptoms. Many patients have chronic problems with pain, wounds, bleeding and / or they have a cosmetically disfiguring condition. Predicting the performance of a specific type of treatment can be very difficult.
Until now, there are some studies that have considered the effect of bleomycin / pingyangmycin (China) and ethanol in the treatment of vascular malformations. To our knowledge there is no prospective or retrospective studies that compare the efficacy and side effects of bleomycin and sodium tetradecyl sulfate (Fibrovein ™) in the treatment of VM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bleomycin + Fibrovein | Experimental | Drug: Bleomycin + Fibrovein1) Fibrovein 3% foamed with air 50/ 50. Total volum injected is the same as volume of malfomation. Volume of malformation estimated by contrast media injection before sclerotherapy. 2) wait 5 minutes 3) Bleomycin 1000 iu / ml. Injected volume same as volume of Fibrovein foam. |
| Bleomycin | Active comparator | Drug: BleomycinBleomycin 1000 iu/ ml. Total volum injected is the same as volume of malfomation. Volume of malformation estimated by contrast media injection before sclerotherapy. |
| Natrium Tetradecyl Sulphate (Fibrovein ) | Experimental | Drug: FibroveinFibrovein 3% foamed with air 50/ 50. Total volum injected is the same as volume of malfomation. Volume of malformation estimated by contrast media injection before sclerotherapy. |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Venous malformation
- Must be able to fill in questionary form
- Must be able to sign informed consent form
Key exclusion criteria (4 listed)
- Kidney disease
- Lung disease
- Pregnancy or not willing to safe contraception
- Allergy to Bleomycin or Fibrovein
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BleomycinAlso: Bleomycin BaxterIntralesional | Drug | Bleomycin |
| FibroveinAlso: Fibrovein S.T.D pharmaceutical products LTDIntralesional | Drug | Natrium Tetradecyl Sulphate (Fibrovein ) |
| Bleomycin + FibroveinAlso: Bleomycin Baxter + Fibrovein pharmaceutical productsIntralesional | Drug | Bleomycin + Fibrovein |
Primary outcome
Intesity, frequency and type of pain.
Time frame: 1 year
Pain will be measured before, during and after treatment. It will be asked about type, characteristics and intensity of pain. Using the Visual Analog Score 0-10, 0 beingno pain,10 being maximum pain, will be used in this matter.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Abildgaard, Phd study director
Oslo Universitetssykehus, Rikshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bleomycin, Fibrovein and Bleomycin + Fibrovein in people with Venous Malformation, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intesity, frequency and type of pain. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.